This invention relates methods and apparatuses for use in association with clinical trials and in particular with methods and apparatuses that include confirming that the correct medication has been administered.
The clinical trial phase in the development of a pharmaceutical product involves providing the developed drug to ever increasing numbers of subjects in test groups, and monitoring their reactions over an extended period. This monitoring is an integral part of the drug development process, as it provides the complex test bed of variables against which the pharmaceutical product must perform its desired effect.
During a typical trial phase I, a small number of healthy volunteers test the drug for safety and help to determine the proper dosage. The focus is on questions like how the drug is absorbed by the body, metabolized and excreted, and what is its duration of action. Phase I often lasts approximately one year. A typical phase III focuses on whether or not the drug actually works. It is used by 100 to 300 patients to study its effectiveness and any side effects, and usually lasts 2 to 3 years. Phase III focuses on side effects with a test patient base of 3,000 to 10,000. The effects of the drug over a long term, the proper dosage, and the range of side effects are the products of the analysis, and may take 3 to 4 years to complete
Until very recently, the mountains of patient diary and case report form data associated with these trial phases have been collected and recorded only on paper during visits to Clinical Research Coordinators (CRCs) to obtain refills of trial medication. In addition to concerns regarding completeness and accuracy, the task of merely organizing and xe2x80x98cleaningxe2x80x99 this data, and preparing paper reports for submission to approval bodies, is formidable. This remains a major bottleneck to progress in the development of new drugs. This is the most complex and time-consuming part of drug discovery and development. The delays incurred in the checking, re-checking, entering and transmitting of data all translate into very significant delays in analysis. The often poor quality of the data results in trial analysis that is not as trustworthy as the FDA would like. Every day of delay costs drug companies millions of dollars. Up to 30% of pharma development budgets are spent on making sure collected trial data is accurate. The number of drug trials conducted is increasing steadily, so the trials must become more efficient in their use of research budgets.
A transition to electronic data capture is underway. Recently pharma companies have been investing in web based systems for entering trial data (CRFs). The fewer number of people that handle the data, the higher likelihood that it is xe2x80x98cleanxe2x80x99. By shortening the path from data entry to the clinical trial database, researchers can gain much faster access to data of a much higher quality. Increasingly researchers want real time access to the data so that they can react quickly to detected problems and make adjustments to the trial.
Drug companies are trying to standardize the data they collect on a global basis for their trials databases (making fields the same name, type, units etc. is essential when building a database). They must also re-engineer the processes they use to conduct the trials, along with the technologies. Changing one without the other can leave the results short of the intended improvement. When operating on a global basis, it is important not to assume a networking infrastructure that cannot be relied upon locally (e.g. telecom and data networks, Internet access, etc.).
Privacy remains an issue, but modern safeguards through data encryption can virtually eliminate or at least reduce the risk. Names and other personal identifying information can be completely removed from any communicated data. As banking moves to consumer web transactions backed by security, health care professionals are increasingly more accepting of electronic record keeping.
Accordingly it would be advantageous to provide a system for data collection that is easy to use and reliable. Further it would be advantageous if such a system is portable.
The present invention is a method for conducting clinical trials for a medication that uses a unique identifier, a clock and a smart memory associated with the medication. Information regarding a method of calculating a next take time is received. It is determined if an identifier field on the smart memory is empty and, if empty, the unique identifier is written onto the smart memory. If not empty, it is determined if the identifier in the identifier field is not the unique identifier and if not then exiting. On the other hand, if the unique identifier is present in the identifier field: then calculating the next take time; storing a next take time; and prompting at the next take time. The time on the clock is stored as a take time. In addition, a subject diary form is displayed and subject information in regard to subject diary form is stored.
The clinical trial subject prompter (CTSP) of the present invention provides a platform that integrates medication prompting and electronic patient diary forms (subset of case report forms) for use by clinical trial subjects. The CTSP helps to solve some of the problems in conducting clinical trials and helps to ensure compliance with dosing regimen instructions by the clinical trial subjects.
The CTSP enables Clinical Research Coordinators (CRCs) to enforce the entry of patient diary data with each dose, providing longitudinal (spanning time) depth to the data that supports analysis by investigators (patient diary data can include both subjective responses and parametric data like temperature, weight, heart rate, etc.). Further it enables the integration of non-trial medications with trial medications for both compliance and longitudinal diary data features. The data collected on the CTSP platform may be stored on a variety of media types and retrieved using a variety of connection technologies. The CTSP platform may be integrated into existing and future electronic data capture (EDC) architectures for the automation of clinical trial data management (e.g. Oracle Clinical database). The CTSP may be integrated with consumer prompting device described in detail in U.S. patent application Ser. No. 09/359,322 filed on Jul. 23, 1999 entitled PACKAGE WITH INTEGRATED CIRCUIT CHIP EMBEDDED THEREIN AND SYSTEM FOR USING SAME which is incorporated herein by reference and the CTSP complements it by extending its use into the clinical trial data management market.
Further features of the invention will be described or Will become apparent in the course of the following detailed description.